MOSCOW, Russia I May 13, 2016 I NeuroMax Ltd and its development partner, Bionevia LLC, today announced the completion of the enrollment within NM-ARI-231, a Phase 2b randomized, double-blind, placebo-controlled twelve month, chronic efficacy and safety study of BNV-222 (diepalrestat) in adult subjects with diabetic peripheral neuropathy. Four hundred (400) subjects were enrolled in 27 sites in Russia. The ongoing Phase 2b clinical trial evaluates efficacy on motor nerve conduction velocity, clinical outcomes, and visual acuity.
“While there are many drugs available to patients and physicians for the treatment of the symptoms of this disease, there are no therapies available to change the rate of progression of the underlying disease. This drug holds the promise to have a meaningful effect on the outcome of the major complications of Type 2 diabetes,” – said Vera Bril, MD, Professor of Medicine (Neurology) at the University of Toronto, Director of Neurology at Mount Sinai Hospital, and the Principal Investigator of the Phase 2b study.
“Assuming a positive trial outcome, Bionevia is targeting an End of Phase 2 Meeting with the FDA for the second half of 2017 where we hope to establish a clinical path forward for approval in the US,” – said Timothy Barberich, Chairman of Bionevia.
“Together with previously conducted supporting preclinical and clinical studies of BNV-222, which showed a favorable safety profile, the companies believe that the current Phase 2b trial results will enable the filing and approval for marketing in Russia,” – said Julia Moskot, NeuroMax Program Director.
About BNV-222
BVN-222 is a potential disease modifying, first-in-class treatment for slowing or arresting diabetic neuropathy, a progressive disease. BNV-222 is a novel extended release formulation of diepalrestat, a cocrystal of epalrestat, a reversible aldose reductase inhibitor which blocks the breakdown of excess blood glucose into sorbitol, preventing long-term nerve and tissue damage.
About NeuroMax
NeuroMax Ltd is a private biotechnology company, founded in 2010, with the purpose to develop and market launch innovative products for the treatment of central and peripheral nervous system diseases in Russia.
About Maxwell Biotech Venture Fund
Maxwell Biotech Venture Fund is the first Russian venture fund fully dedicated to investment in the life sciences sector. The fund has been created with the participation of the Russian Venture Company (RVC).
SOURCE: Maxwell Biotech
Post Views: 37
MOSCOW, Russia I May 13, 2016 I NeuroMax Ltd and its development partner, Bionevia LLC, today announced the completion of the enrollment within NM-ARI-231, a Phase 2b randomized, double-blind, placebo-controlled twelve month, chronic efficacy and safety study of BNV-222 (diepalrestat) in adult subjects with diabetic peripheral neuropathy. Four hundred (400) subjects were enrolled in 27 sites in Russia. The ongoing Phase 2b clinical trial evaluates efficacy on motor nerve conduction velocity, clinical outcomes, and visual acuity.
“While there are many drugs available to patients and physicians for the treatment of the symptoms of this disease, there are no therapies available to change the rate of progression of the underlying disease. This drug holds the promise to have a meaningful effect on the outcome of the major complications of Type 2 diabetes,” – said Vera Bril, MD, Professor of Medicine (Neurology) at the University of Toronto, Director of Neurology at Mount Sinai Hospital, and the Principal Investigator of the Phase 2b study.
“Assuming a positive trial outcome, Bionevia is targeting an End of Phase 2 Meeting with the FDA for the second half of 2017 where we hope to establish a clinical path forward for approval in the US,” – said Timothy Barberich, Chairman of Bionevia.
“Together with previously conducted supporting preclinical and clinical studies of BNV-222, which showed a favorable safety profile, the companies believe that the current Phase 2b trial results will enable the filing and approval for marketing in Russia,” – said Julia Moskot, NeuroMax Program Director.
About BNV-222
BVN-222 is a potential disease modifying, first-in-class treatment for slowing or arresting diabetic neuropathy, a progressive disease. BNV-222 is a novel extended release formulation of diepalrestat, a cocrystal of epalrestat, a reversible aldose reductase inhibitor which blocks the breakdown of excess blood glucose into sorbitol, preventing long-term nerve and tissue damage.
About NeuroMax
NeuroMax Ltd is a private biotechnology company, founded in 2010, with the purpose to develop and market launch innovative products for the treatment of central and peripheral nervous system diseases in Russia.
About Maxwell Biotech Venture Fund
Maxwell Biotech Venture Fund is the first Russian venture fund fully dedicated to investment in the life sciences sector. The fund has been created with the participation of the Russian Venture Company (RVC).
SOURCE: Maxwell Biotech
Post Views: 37
